ARIAD Pharmaceuticals, Inc., today announced top-line data showing that ridaforolimus, an investigational oral mTOR inhibitor, met the primary endpoint of improved progression-free survival (PFS) compared to placebo in the Phase 3 SUCCEED trial conducted in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy.

"Patients with metastatic soft-tissue and bone sarcomas have extremely limited treatment options available to them," stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "These top-line data illustrate how devastating metastatic sarcomas can be, even in patients who have responded favorably to conventional chemotherapy. We are very pleased with the positive outcome of the SUCCEED trial and the statistically significant improvement in progression-free survival in those patients treated with oral ridaforolimus."

The SUCCEED trial is a randomized (1:1), placebo-controlled, double-blind study of oral ridaforolimus administered at 40 mg/day (five of seven days/week) in patients with metastatic soft-tissue or bone sarcomas who demonstrated a favorable response to prior conventional chemotherapy. Oral ridaforolimus was granted a Special Protocol Assessment (SPA) by the U.S. Food and Drug Administration for the SUCCEED trial. The European Medicines Agency has also provided protocol advice regarding the trial design as part of its Protocol Assistance program.